Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials

Abstract

Background

Using a three-pronged acne treatment approach—combining an antibiotic, antimicrobial agent, and retinoid—may provide greater efficacy than monad or dyad treatments. Herein are the dermal sensitization, irritation, safety, and tolerability results from phase 1 and 2 studies of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) polymeric mesh gel.

Methods

Two phases 1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase 2 (NCT03170388) double-blind, randomized, parallel-group, and vehicle-controlled study was conducted over 12 weeks in participants aged ≥9 years with moderate-to-severe acne.

Results

A total of 1,020 participants (IDP-126 gel, vehicle, or 1 of the 3 dyad gels [phase 2 only]) were included across the 3 studies (safety populations: n = 1,004). In the phase 1 studies, IDP-126 had no confirmed sensitization or contact dermatitis. IDP-126 (deemed “moderately irritating”) was significantly less irritating than commercially available BPO 2.5%/adapalene 0.3% gel.

Conclusions

The results from these three studies show that the triple-combination IDP-126 had a positive safety profile and was well tolerated in healthy participants and those with moderate-to-severe acne

Keywords:

• Irritation
• benzoyl peroxide
• adapalene
• clindamycin

Acknowledgements

Medical writing support was provided by Lynn M. Anderson, Ph.D. and Jacqueline Benjamin, Ph.D. of Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.

Disclosure statement

Zoe D. Draelos received research funding from Ortho Dermatologics. Emil A. Tanghetti has served as a speaker for Novartis, Ortho Dermatologics, Sun Pharma, Lilly, Galderma, AbbVie, and Dermira; served as a consultant/clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a stockholder for Accure. Leon H. Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Neal Bhatia has served as advisor, consultant, and investigator for AbbVie, Almirall, Biofrontera, BI, Brickell, BMS, EPI Health, Ferndale, Galderma, InCyte, ISDIN, J&J, LaRoche-Posay, LEO Pharma, Ortho Dermatologics, Regeneron, Sanofi, SunPharma, Verrica, and Vyne. Joshua A. Zeichner has served as advisor, consultant, or speaker for AbbVie, Allergan, Dermavant, Dermira, EPI Health, Galderma, Incyte, Johnson and Johnson, L’Oreal, Ortho Dermatologics, Pfizer, Procter and Gamble, Regeneron, Sun Pharma, UCB, Unilever, and Vyne. Jeffrey L. Sugarman is a consultant for Ortho Dermatologics, Bausch Health, Regeneron, Sanofi, Verrica, and Pfizer. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly.

Data availability statement

Data available upon request.

Additional information

Funding

The studies were funded by Ortho Dermatologics. Medical writing support for this article was also funded by Ortho Dermatologics.